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Animal feed additives
Animal feed claims
Animal testing
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Biosimilar medicinal product
Cascade
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Column by the chairman: 'On medicines'
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Line extension
MEB Advisory Board
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Marketing discontinuation, suspension and shortages
Medicinal gas marketing authorisation
Mutual recognition procedure
National contact person for pharmacovigilance
National procedure
New active substance
Nomenclature, excipients, abbreviated indications
Opium Act and veterinary medicinal products
Organisation Management Service (OMS)
Our story: Good medicines used better
Our tasks
PSMF
Package leaflet
Paediatric medicinal product
Parallel distribution
Parallel import
Parallel procedures: faster assessment of medicines
Parallel trade in veterinary medicinal products
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Periodic safety update reports (PSUR)
Permission to carry out tests with additives for animal feed
Pharmacovigilance communication plan
Planning tool for application procedures
Production and/or distribution licence application, change or withdrawal
Proposed withdrawals and patients' interest
QR code
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Recall of veterinary medicinal product
Register of animal feed additives
Register of licences
Registration procedure for specific pets
Relevant legislation
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Reporting a product defect
Reporting adverse events
Reporting adverse events during clinical trials
Reporting an adverse event
Requirements for importation (I)
Responsibilities following marketing authorisation
Risk management plan
SPC, labelling and package leaflet veterinary medicinal products
Science
Scientific and regulatory advice
Signal management
Site clearance
Starting materials
Storage, transport and delivery of veterinary medicinal products
Submission of a dossier
Submission via CESP
Summary of product characteristics (SmPC)
TSE requirements
Technical validation
Temporarily supply of a medicinal product in a different packaging
The Agency
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Traditional herbal medicinal product
Types of marketing authorisation
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Use of herbs in animals
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Veterinary medicines
Marketing authorisation – medicines for human use
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Disinfectant products: Distinguishing between biocidal products and medicinal products (human and veterinary)
Policy document | 01-05-2013
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